Merck Millipore have expanded its Provantage® Biodevelopment Services to include a Clone Generation Service. With this addition, the Company now provides a full range of services for optimizing yield, productivity, consistency and efficiency of clinical scale drug products.

The new Clone Generation Service includes expression of recombinant proteins such as hormones, growth factors and mono- and bi-specific monoclonal antibodies. Customers can choose from DG44 and CHO-S cell lines, both of which are widely used for reliable and high-yield production of biologics. Availability of two cell lines offers greater flexibility to meet both the technical requirements and business objectives of customers. While the DG44 cell line offers freedom for process development, the CHO-S line can be more cost effective. Our team works with customers to evaluate specific needs and select the best approach.

Every clone generation is fully documented to ensure traceability from the source and demonstrate that the cell is clonal, making the cells usable for clinical production, IND submission and acceptance.

"Development of a high-quality, high-expressing cell line is a critical, early step in the production of a biologic drug," said Udit Batra, president and CEO of Merck Millipore. "The cell line not only defines the product, but also drives much of the yield and titer during bioproduction. Our Provantage® team and services optimize clone generation as well as the entire clinical scale process, setting the stage for manufacturing success."

Clone generation includes DNA synthesis of the sequence encoding the biologic, cloning of the sequence in a vector, transfection, and preparation of stable pools of producing cells, amplification of the expression cassette and subcloning of high-producing cells. The final deliverable is a pre-master cell bank of high-producing clones and a cell line generation report.

Provantage® Biodevelopment services also include media and feed screening to optimize titer and yield. In addition to upstream services, small scale production for preclinical studies, process development and production of GMP batches support development of the drug manufacturing process.